Human Immunodeficiency VirusTIARASNCT02923141
Trauma Intervention for Affect Regulation, AIDS, and Substances
A study testing Neutral Writing, Expressive Writing and Contingency Management in people with Human Immunodeficiency Virus and Substance Related Disorder, run by University of Miami at 1 site in United States.
Trial summary
The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Substance Related Disorder, Post Traumatic Stress Disorder
- What is being tested?
- Neutral Writing, Expressive Writing and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- woman or trans woman
- substance use
- elevated PTSD symptoms
- HIV care difficulties
Who cannot join
- not HIV positive
- no substance use
- men
- no HIV care difficulties
- no history of trauma
Trial locations and contacts
1 site in 1 country.
About this study
The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women.
- Being tested
- Neutral Writing, Expressive Writing, Contingency Management
- Keywords
- substance use, trauma, HIV, viral load, women
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral WritingBehavioural
Expressive WritingBehavioural
Contingency ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Neutral Writing + Contingency Management | Active comparator | Participants will attend four attention-matched control sessions, consisting of face-to-face administration of psychological measures and neutral writing exercises. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result. Receives: Behavioral: Neutral Writing; Behavioral: Contingency Management |
| Expressive Writing + Contingency Management | Active comparator | Participants will attend four expressive writing sessions focusing on traumatic or stressful events. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result. Receives: Behavioral: Expressive Writing; Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HIV RNA Copies/mL
Measured: 6 months
Secondary outcomes (6)
Increase in T-helper (CD4+) cell count
Measured: 6 months
Reduction in HIV transmission risk
self-reported condomless, serodiscordant sex and HIV viral load greater than 200 copies/mL
Measured: 6 months
Decrease in stimulant use
self-report
Measured: 6 months
Decrease in stimulant use
urine toxicology screening
Measured: 6 months
Decrease in post-traumatic stress disorder (PTSD) symptoms
self-report measure: PTSD Checklist for DSM-5
Measured: 6 months
Decrease in depressive symptoms
self-report measure: Centers for the Epidemiologic Study of Depression (CES-D)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Carrico, University of Miami
- Investigators
- Adam Carrico, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923141
- Sponsor's protocol ID
- 20160744
- Acronym
- TIARAS
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jemison D, Jackson S, Oni O, Cats-Baril D, Thomas-Smith S, Batchelder A, Rodriguez A, Dilworth SE, Metsch LR, Jones D, Feaster DJ, O'Cleirigh C, Ironson G, Carrico AW. Pilot Randomized Controlled Trial of a Syndemics Intervention with HIV-Positive, Cocaine-Using Women. AIDS Behav. 2019 Sep;23(9):2467-2476. doi: 10.1007/s10461-019-02625-2.
PubMed 31407212
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Intervention for Affect Regulation, AIDS, and Substances
- ClinicalTrials.gov ID
- NCT02923141
- Acronym / sponsor ID
- TIARAS / 20160744
- Keywords
- substance use, trauma, HIV, viral load, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral Writing + Contingency Management | Active comparator | Behavioral: Neutral Writing, Behavioral: Contingency ManagementParticipants will attend four attention-matched control sessions, consisting of face-to-face administration of psychological measures and neutral writing exercises. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result. |
| Expressive Writing + Contingency Management | Active comparator | Behavioral: Expressive Writing, Behavioral: Contingency ManagementParticipants will attend four expressive writing sessions focusing on traumatic or stressful events. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV positive
- woman or trans woman
- substance use
- elevated PTSD symptoms
- HIV care difficulties
Key exclusion criteria (5 listed)
- not HIV positive
- no substance use
- men
- no HIV care difficulties
- no history of trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral Writing | Behavioural | Neutral Writing + Contingency Management |
| Expressive Writing | Behavioural | Expressive Writing + Contingency Management |
| Contingency Management | Behavioural | Expressive Writing + Contingency Management, Neutral Writing + Contingency Management |
Primary outcome
Reduction in HIV RNA Copies/mL
Time frame: 6 months
6 secondary outcomes
Increase in T-helper (CD4+) cell count
Time frame: 6 months
Reduction in HIV transmission risk
Time frame: 6 months
Decrease in stimulant use
Time frame: 6 months
Decrease in stimulant use
Time frame: 6 months
Decrease in post-traumatic stress disorder (PTSD) symptoms
Time frame: 6 months
Decrease in depressive symptoms
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Derived from this study: PubMed 31407212Jemison D, Jackson S, Oni O, Cats-Baril D, Thomas-Smith S, Batchelder A, Rodriguez A, Dilworth SE, Metsch LR, Jones D, Feaster DJ, O'Cleirigh C, Ironson G, Carrico AW. Pilot Randomized Controlled Trial of a Syndemics Intervention with HIV-Positive, Cocaine-Using Women. AIDS Behav. 2019 Sep;23(9):2467-2476. doi: 10.1007/s10461-019-02625-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Carrico, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral Writing, Expressive Writing and Contingency Management in people with Human Immunodeficiency Virus and Substance Related Disorder, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in HIV RNA Copies/mL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.